Device having a funnel for guiding surgical tools into a body cavity

ABSTRACT

The trocar assembly of the present invention includes a tubular body portion, a sleeve, a unidirectional sealing means included within the sleeve and a funnel portion mounted around the sleeve. A perforating tool is insertable through the funnel, through the unidirectional sealing means and thence through the tubular portion of the trocar assembly into the body of a patient. All portions of the trocar assembly of the present invention are formed from materials which may not be readily sterilized by immersion in a sterilizing bath or autoclaving. Thus, the single use trocar assembly of the present invention may be only used once and will be destroyed if an attempt is made to resterilize the entire trocar assembly or any portion thereof.

RELATED APPLICATION

This is a continuation of application Ser. No. 08/896,404, filed Jul.18, 1997 of U.S. Pat. No. 5,957,947.

FIELD OF THE INVENTION

The present invention relates to a trocar assembly which includes alaparoscopic trocar and trocar sleeve (also called a cannula).

BACKGROUND

Laparoscopy is a method for the exploration of the peritoneal cavitywherein a sterile gas is blown or insufflated into the peritoneal cavitythrough the tubular portion or cannula section. The tubular portion orcannula section of the trocar assembly is connected to a gas source sothat the pressure of the gaseous pocket within the peritoneal cavity maybe maintained. This gaseous pocket within the peritoneal cavity is knownas a pneumoperitoneum.

The visual exploration of the organs within the peritoneal cavity orother areas of the body is carried out by means of an endoscope or asimilar device which passes through the tubular portion or cannulasection of a trocar assembly after the tubular portion of a trocarassembly has been put in place in an abdominal wall. Similarly, one ormore additional cannulas may be introduced into the pneumoperitoneum forthe introduction of various tools to allow additional procedures such asbiopsies.

The tubular portion or cannula section of the trocar assembly is aparticularly important element, because it must pass through the fleshor tissue surrounding the peritoneal cavity without causing anypostoperative trauma, yet still provide for anchorage to the abdominalwall. Above all, the tubular portion of the trocar assembly must assurethat a seal is formed between the pneumoperitoneum and the atmosphereexternal to the peritoneal cavity.

Currently, most trocar assemblies are made of metal to facilitate theirsterilization and re-use. Specifically, stainless steel is most commonlyused. As far as the sealing means within the trocar assembly areconcerned, other synthetic materials are used.

In general, the body portion of prior art trocar assemblies consists ofa collection of detachable elements which allow access to the sealingmeans. After the insertion of the trocar assembly into the patient, thesealing means within the trocar assembly becomes contaminated by bloodand other secretions. Thus, these prior art trocar assemblies must bedisassembled and cleaned before they can be sterilized for reuse.Consequently, in prior art trocar assemblies that may be taken apart forcleaning, some type of connection means, threadable or otherwise, mustbe provided between the different parts of the trocar assembly. In somenewer prior art trocar assemblies, synthetic materials are used in placeof stainless steel. In these newer trocar assemblies, the syntheticmaterials which are used to seal the pneumoperitoneum from theatmosphere are generally not sterilizable. Such materials are describedin European Patent Nos. A-564,373 and A-541,970.

The reusable character of the prior art trocar assemblies requires thatthey be made of expensive materials, or have a complex and expensivedesign. Complex and expensive designs provide significant drawbacks forthe user. These drawbacks are in addition to those drawbacks whichresult from the cost of cleaning and re-sterilizing the trocarassemblies.

To overcome these drawbacks, it has been found that less expensivedisposable trocar assemblies may be used. French Patent Nos. A-2,691,625and A-2,694,181 disclose such disposable trocar assemblies. Despite thefact that the trocar assemblies are disposable, it has been found thatsome medical care personnel attempt to sterilize these disposable trocarassemblies for re-use.

French Patent No. A-2,691,625 defines the of a fibrous, syntheticmaterial for making trocar assemblies. This fibrous, synthetic materialis used for the manufacture of both the tubular body portion or cannulasection of the trocar assembly, and, also the removable perforationdevice. Thus, the fibrous synthetic material allows for a reduction inthe manufacturing cost of the trocar assembly, but it does not preventreuse of the trocar assembly.

French Patent No. A-2,694,181 describes, more particularly, thestructure of a sealing means in the tubular portion of cannula sectionof a trocar assembly. This patent does not address the problem ofpreventing reuse of the sealing means in a trocar assembly.

The object of the present invention is to provide a laparoscopic trocarassembly which is inexpensive to make, provides a seal to prevent theescape of gas back through the trocar assembly, and yet cannot bere-sterilized and used again Thus, once the trocar assembly is used itshould be rendered unusable.

SUMMARY OF THE INVENTION

The trocar assembly of the present invention includes a tubular bodyportion or cannula section made of a synthetic material. The tubularbody portion includes means which retain it in abdominal wall and alsoprovides for the guidance of a removable device, typically alaparoscopic trocar, used to perforate the tissue surrounding theabdominal cavity. The removable device for perforation of the tissuesurrounding the abdominal cavity is mounted so that it can slide axiallywithin the tubular body portion. Also mounted within the tubular bodyportion are sealing means which are capable of cooperating with theperforation device, or with other types of surgical tools, to seal theperforated body cavity from the escape of gas. The sealing meansincludes a unidirectional closing means mounted within a sleeve at theend of the tubular body portion of the trocar assembly. The sleeve isfurther extendable by a guidance funnel, which is mounted on theexternal portion of the sleeve to be coaxial with the bore of thetubular body.

The unidirectional closing means is a shouldered disk which is mountedwithin the sleeve at the end of the tubular body portion of the trocarassembly. The shouldered disk unidirectional closing means is mountedunder a socket within in the sleeve. The sleeve has a circular lipforming a sealing joint where it contacts the guidance funnel. Thesocket and the shouldered disk form a subassembly which is immobilizedand permanently retained in the sleeve of the tubular body by a cover.The synthetic material from which this subassembly is formed is selectedfrom those materials which cannot be sterilized by immersion in the typeof sterilizing bath found in most hospitals. Similarly, the syntheticmaterial from which the tubular body and the cover are made is selectedfrom those materials which cannot be sterilized by insertion into thetype of sterlizing autoclave found in most hospitals.

Because of the structure of the present invention, notably the lockingof the cover to the sleeve portion to the tubular body, the subassemblywhich includes the unidirectional closing means and the sealing meanscannot be extracted from the trocar assembly. This permanent mountingprevents, prior to any re-sterilization, the removal of any blood orsecretions that may soil the subassembly. Moreover, the sterilizationmeans conventionally used in hospitals, that is sterilization byautoclaving or sterilization by immersion in a sterilizing bath, willactually cause the partial destruction of one or more of the componentsof the trocar assembly. Specifically, sterilization by autoclaving orsterilization by immersion will destroy one or more of the tubular bodyportion, the cover, and the closing and sealing subassembly. Thedestruction of one or more parts of the trocar assembly renders itunusable.

As a result, the trocar assembly of the present invention, in additionto having a structure and a composition of a synthetic material, whichleads to very low costs, cannot be resterilized by means readilyavailable in a hospital environment. Consequently, any attempt to rendera contaiminated trocar assembly, made according to the presentinvention, reusable by either immersion bath sterilization or autoclavesterilization will render it unusable.

In one embodiment of the invention, the removable tissue perforationdevice is also made of a synthetic material. This removable tissueperforation device includes, at its end, a conical part having an angleat the center of between 35° and 50°, and two flat areas which form adyhedron having an angle of between 60° and 75° The apical side of thedyhedron is slanted with respect to the longitudinal axis of the deviceby 20° to 40°. It also extends beyond longitudinal axis of the device toform an off-center tip.

This off-center tip combines the advantages of both a conical shape anda pyramidal shape without presenting any of their drawbacks. Suchdrawbacks are difficulty of penetration for the conical tip, and atraumatizing character for a pyramidal tip. In addition, the selectedangles allow a cutting edge to be obtained using synthetic materialswhich do not have the same hardness as metals.

Other characteristics and advantages of the present invention willbecome apparent from the following description made with reference tothe accompanying drawings in which one embodiment of the trocar assemblyof the present invention is illustrated.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is an exploded perspective view showing the different componentsof the trocar assembly of the present invention;

FIG. 2 is a side view, in longitudinal section, of the trocar assembly,where its elements have been assembled one with another;

FIG. 3 is a partial side view, in elevation, of the tip of theperforation device;

FIG. 4 is an end view of the perforation device;

FIG. 5 is a cross-sectional view along V—V of FIG. 3;

FIG. 6 is a partial view in cross-section showing, in an enlarged scale,the shape of the threads provided on the tubular body.

DESCRIPTION OF THE EMBODIMENTS

In general, the laparoscopic trocar assembly shown in the drawingsconsists of a tubular body portion 2, a removable perforation device 3,a sealing means 4, a unidirectional closing means 5, and a cover 6.

The tubular body portion 2 is integrally connected to a sleeve 7 whichhouses the sealing means 4 and the closing means 5. The tubular part 2 aof the body 2 has external threadings 9 and it includes a beveled end 10opposite the sleeve 7.

According to the invention, the tubular body portion 2 and the cover 6are made of a synthetic material which cannot be sterilized in anautoclave, for example, polyethylene. The skirt 6 a of the cover 6,which is slipped over the outside of the sleeve 7 of the body 2, isextended, outwardly by a funnel 12. The funnel 12 is coaxial with thebore 2 b of the tubular body portion and it provides means for guidingone or more surgeon's tools through the tubular body portion 2. Thepermanent connection between the skirt 6 a and the sleeve 7 is assuredby a peripheral rib 13 which projects from sleeve 7, which in turn locksinto a matching groove 14, provided inside the skirt 6.

FIG. 2 shows that, when these two elements are assembled, they firmlyretain the subassembly 15 which includes the sealing means 4 and theunidirectional closing means 5 in the sleeve 7. The sealing means 4 andthe unidirectional closing means S are advantageously made of asynthetic material such as a silicon elastomer which cannot besterilized by immersion into a sterilizing bath, for example, aglutaraldehyde bath.

The unidirectional closing means 5 is a disk 5 a which includes adiametral slit 5 b and a shoulder 5 c.

The sealing means is a socket 4 a with a diametral wall 4 b. A bore 16,shown in FIG. 2 delimits the sealing lip 4 c. The shoulder Sc of thedisk is slipped onto the end of the socket 4 a to form the subassembly15.

As shown in FIG. 2, the subassembly 15 is mounted directly within theinterior of the sleeve 7, which is generally circular in shape. Thesubassembly 15 is immobilized as far as longitudinal translationalmovement by resting, on one side, against a shoulder 17 within thesleeve 7 and, on the other side, by the bottom 18 of the funnel assembly12 which contacts sealing lip 4 c on top of the sleeve 7.

The removable perforation device 3 is also made of a synthetic material.Specifically, the removable perforation device consists essentially of arod 20 which has an integrally connected push button 22 on its externalend and is integrally connected to a perforating head 23 on the oppositeend. The perforating head 23 includes cylindrical part 23 a, which endsin a conical part 23 b.

FIGS. 3-5 show that the conical part 23 b has an angle of 35° to 50° atits center. Preferably this angle is about 42°. The conical part 23 balso includes two flat areas 24 a, and 24 b which transversely form adyhedron whose angle a at the apex is from 60° to 75°. Preferably, thisangle is about 68°. The apical edge 25 of the dyhedron is slanted withrespect to the longitudinal axis, x′-x of the device 3 by an angle bhaving a value of about 20° to 40°. Preferably, this angle is about 24°,so that the tip 26 is off-center.

Because of the disclosed arrangement, the head 23 enables cutting, butit does not cause trauma, and the cutting is satisfactory even if theentire device 3 is made of a synthetic material which has a lesserhardness than steel, for example a polyacetal plastic.

It should be noted that the synthetic material which constitutes theremovable device 3 for perforation is also selected from materials whichcannot be sterilized at temperatures normally found in an autoclave.

After initial manufacture, the different elements of the trocar assemblyare assembled and the perforation device 3 is put in place within thetubular body 2, and the entire trocar assembly is sterilized withethylene oxide. Sterilization by ethylene oxide is expensive and notgenerally available to hospital departments which typically usesterilization by autoclaving at 140° C. or sterilization by immersion ina bath of a sterilizing liquid.

The use of the trocar assembly of the present invention is the same asthat of existing prior art trocar assemblies. That is, after the area oftissue of the abdominal wall to be traversed has been identified, thesurgeon presses the end of the tubular body 2 against this area. Thesurgeon then presses on the push rod of the perforation device 3, sothat the head 23 of the perforation device perforates the body tissue.When the perforation is complete, the tubular body portion 2 is engagedin the tissue wall by guidance on the head 23, and then by threading thetubular body portion 2 in the tissue using the threads 9 formed on theexterior portion of the tubular body portion 2.

FIG. 6 shows that the threads 9 have a generally triangular shape, butwith straight flanks 28 which improve the attachment to the threads 9 tobodily tissue.

This threading of the tubular body portion 2 into the tissue assures anexcellent maintenance of the trocar assembly in the tissue wall. Incombination with the funnel 12, the trocar assembly of the presentinvention facilities the guidance of the surgeon's tools. Additionally,it frees the hand of the surgeon who, when using prior art trocarassembly devices, had to hold the trocar during the introduction of atool through the bore 2 b of the insertion tube.

At the end of the examination or the operation, the trocar assembly isremoved by simply unscrewing it and then discarding it, where it cannotbe reused. Indeed, blood and other body secretions which contaminate thebore 2 b, and also the subassembly 15, cannot be cleaned because thesubassembly cannot be dismantled to be re-sterilization. Moreover, anyattempt at re-sterilization by the means frequently used in hospitalenvironments results in the partial destruction of one or more parts ofthe trocar assembly, that is destruction by melting of either thetubular body portion 2, the cover 6, or of the perforation device 3 bytreatment in an autoclave and the destruction of the closing and sealingsubassembly 15 in the case of sterilization by immersion in asterilizing bath.

The risk of the reuse of an unclean and unsterilized trocar assembly isthen made impossible for hospital personnel that have been informedabout prophylactic procedures. In addition, the destruction of thetrocar assembly of the present invention by attempts at re-sterilizationmakes the trocar effectively not reusable if re-sterilization isattempted.

While the single use trocar assembly of the present invention has beendescribed by reference to its preferred emobodiment, those of ordinaryskill in the art will understand that numerous other emobodiments may bemade. Such other emobodiments shall fall within the scope and meaning ofthe appended claims.

We claim:
 1. A single use non re-sterilizable device for guiding one ormore surgical tools into a body cavity, said device comprising: (a) atubular body portion, said tubular body portion having a first end and asecond end, wherein said first end of said tubular body portion isconstructed and arranged for insertion into a body cavity and saidsecond end of said tubular body portion is formed into a sleeve, saidsleeve having a first outside surface; (b) sealing means constructed andarranged to mount within said sleeve; and (c) a funnel having a guidingportion, a connecting portion and a central portion between the guidingportion and the connecting portion, wherein said connecting portion isattached to said sleeve opposite said tubular body portion with saidsealing means located between said cental portion and said tubular bodyportion, said central portion has an opening which is substantiallycoaxial with the tubular body portion and allows access to the sealingmeans through the central portion when using the surgical tools, saidguiding portion has a third end opposite said central portion, whereinsaid third end has an inside cross-sectional dimension perpendicular tothe axis of the tubular body portion greater than the cross-sectionaldimension of the first outside surface, and said guiding portion alsohas an interior surface conducive for guiding the surgical instrumentsto the opening in said central portion, when such surgical instrumentsare placed within the guiding portion for the purpose of insertionthrough said tubular body portion into the body cavity; said tubularbody portion and/or said sealing means being fabricated from a syntheticmaterial that will be destroyed and rendered unusable by immersion intoa sterilizing bath or autoclaving.
 2. The device of claim 1, wherein theinterior surface of the guiding portion is has a truncated cone shape.3. The device of claim 1, wherein the connecting portion isunreleaseably affixed to the sleeve.
 4. In combination with a device forguiding one or more surgical tools into a body cavity, said devicehaving at least (1) a tubular body portion, said tubular body portionhaving a first end and a second end, wherein said first end of saidtubular body portion is constructed and arranged for insertion into abody cavity and said second end of said tubular body portion is formedinto a sleeve, said sleeve having a first outside surface and (2)sealing means constructed and arranged to mount within said sleeve, asignal use non-resterilizable funnel, said funnel comprising: a guidingportion; a connecting portion; and a central portion between the guidingportion and the connecting portion, wherein said connecting portion isadapted for attachment to said sleeve opposite said tubular body portionsuch that said sealing means being located between said cental portionand said tubular body portion, said central portion has an opening whichwhen the connecting portion is attached to the sleeve, the opening issubstantially coaxial with the tubular body portion and allows access tothe sealing means through the central portion when using the surgicaltools, said guiding portion has a third end opposite said centralportion, wherein said third end has an inside cross-sectional dimensionperpendicular to the axis of the tubular body portion greater than thecross-sectional dimension of the first outside surface, said guidingportion also has an interior surface conducive for guiding the surgicalinstruments to the opening in said central portion, when such surgicalinstruments are placed within the guiding portion for the purpose ofinsertion through said tubular body portion into the body cavity; saidfunnel being fabricated from a synthetic material that will be destroyedand rendered unusable by immersion into a sterilizing bath orautoclaving.
 5. The funnel of claim 4, wherein the interior surface ofthe guiding portion is has a truncated cone shape.